U.S. patent number 10,780,230 [Application Number 15/578,341] was granted by the patent office on 2020-09-22 for auto-injector with a delay system.
This patent grant is currently assigned to APTAR FRANCE SAS. The grantee listed for this patent is APTAR FRANCE SAS. Invention is credited to David Fabien, Thomas Gomez, Olivier His, Anthony Saussaye.
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United States Patent |
10,780,230 |
Fabien , et al. |
September 22, 2020 |
Auto-injector with a delay system
Abstract
An autoinjector having a body (1) receiving a reservoir (S)
containing fluid and a piston (P); a piston rod (5) movable by an
injection spring (8) between a primed position and an injection
position; and a visual, audible, and/or tactile indicator for
indicating the autoinjector may be removed from the injection site.
The autoinjector including a retarding system for delaying
actuation of the indicator relative to the end of injection, and
including a dashpot (16) containing a fluid, a piston (19) in the
dashpot, the dashpot or the piston movable in the body during
actuation of the retarding system with the other stationary
relative to the body, resulting in the fluid moving out from the
dashpot through a flow passage (161; 195) to brake movement.
Inventors: |
Fabien; David (Plouarzel,
FR), Gomez; Thomas (Saint Aubin de Nedoc,
FR), Saussaye; Anthony (Louviers, FR), His;
Olivier (Saint Etienne du Vauvray, FR) |
Applicant: |
Name |
City |
State |
Country |
Type |
APTAR FRANCE SAS |
Le Neubourg |
N/A |
FR |
|
|
Assignee: |
APTAR FRANCE SAS (Le Neubourg,
FR)
|
Family
ID: |
1000005067344 |
Appl.
No.: |
15/578,341 |
Filed: |
June 2, 2016 |
PCT
Filed: |
June 02, 2016 |
PCT No.: |
PCT/FR2016/051319 |
371(c)(1),(2),(4) Date: |
November 30, 2017 |
PCT
Pub. No.: |
WO2016/193628 |
PCT
Pub. Date: |
December 08, 2016 |
Prior Publication Data
|
|
|
|
Document
Identifier |
Publication Date |
|
US 20180154084 A1 |
Jun 7, 2018 |
|
Foreign Application Priority Data
|
|
|
|
|
Jun 5, 2015 [FR] |
|
|
15 55163 |
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M
5/2033 (20130101); A61M 5/31511 (20130101); A61M
5/31538 (20130101); A61M 5/3157 (20130101); A61M
5/20 (20130101); A61M 5/32 (20130101); A61M
2205/581 (20130101); A61M 2005/2086 (20130101); A61M
2205/582 (20130101); A61M 2005/2013 (20130101); A61M
2005/208 (20130101); A61M 2205/583 (20130101) |
Current International
Class: |
A61M
5/315 (20060101); A61M 5/32 (20060101); A61M
5/20 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
2011/101380 |
|
Feb 2011 |
|
WO |
|
2013/178512 |
|
Dec 2013 |
|
WO |
|
2015/073740 |
|
May 2015 |
|
WO |
|
Other References
International Preliminary Report on Patentability with a
Translation of Written Opinion issued on Dec. 21, 2017 from the
International Bureau in counterpart International Application No.
PCT/FR2016/051319. cited by applicant .
International Search Report for PCT/FR2016/051319 dated Sep. 19,
2016 [PCT/ISA/210]. cited by applicant .
Written Opinion for PCT/FR2016/051319 dated Sep. 19, 2016
[PCT/ISA/237]. cited by applicant.
|
Primary Examiner: Mendez; Manuel A
Assistant Examiner: Ahmed; Tasnim Mehjabin
Attorney, Agent or Firm: Sughrue Mion, PLLC
Claims
The invention claimed is:
1. An autoinjector comprising: a body receiving a reservoir, said
reservoir containing fluid and including a piston, such as a
pre-filled syringe; a piston rod that is adapted to co-operate with
the piston of said reservoir, said piston rod being movable by an
injection spring between a primed position and an injection
position in which said piston rod has moved the piston of the
reservoir so as to inject the fluid into an injection site; and a
visual, audible, and/or tactile indicator device for indicating to
the user that said autoinjector may be removed from said injection
site; said autoinjector being characterized in that it includes a
retarding system for delaying the actuation of said visual, audible
and/or tactile indicator device relative to the end of injection,
said retarding system including a dashpot containing a fluid, a
piston being arranged in said dashpot, one of said dashpot and of
said piston being movable in translation in said body during
actuation of said retarding system, and the other of said dashpot
and of said piston being stationary relative to said body during
actuation of said retarding system, the movement in translation of
one relative to the other moving said fluid out from said dashpot
through at least one flow passage, such that said movement in
translation is braked, said retarding system comprising said
dashpot containing said fluid, said piston, a locking key, said
injection spring, a pusher element, a support member interposed
between said pusher element and said injection spring, and said
piston rod, said locking key comprising a head, a longitudinal rod,
and an endpiece that is adapted to co-operate with the piston rod,
said head of the locking key being in its blocking position before
triggering the retarding system, in which position it co-operates
with a recess of said pusher element, said piston rod, when it
arrives towards its end-of-injection position, co-operating with
the endpiece of the locking key so as to pull said locking key
axially downwards out from its blocking position, such that said
pusher element is thus no longer prevented from moving in
translation by said locking key.
2. The autoinjector according to claim 1, wherein, during actuation
of said retarding system, said piston is movable in translation in
said body, and said dashpot is stationary.
3. The autoinjector according to claim 2, wherein, during actuation
of said retarding system, said dashpot is prevented from moving in
translation by a frustoconical or sloping wall portion of said body
that co-operates with at least one flexible tab of said dashpot,
said piston, during actuation of said retarding system, preventing
said flexible tabs from deforming radially inwards.
4. The autoinjector according to claim 3, wherein, after actuating
said retarding system, said piston is moved axially relative to
said at least one flexible tab of said dashpot and no longer
prevents it from deforming radially inwards, such that said dashpot
is no longer prevented from moving in translation in said body.
5. The autoinjector according to claim 1, wherein said at least one
flow passage is formed by an axial groove in the dashpot.
6. The autoinjector according to claim 1, wherein said at least one
flow passage is formed by a central hole in the piston.
7. The autoinjector according to claim 1, wherein said pusher
element is axially movable in said body and co-operates with said
piston, such that an axial movement of said pusher element causes
an axial movement of said piston in said dashpot.
8. The autoinjector according to claim 1, wherein said pusher
element includes flexible tabs that, before actuation of the
retarding system, co-operate with a frustoconical or sloping wall
of the body, the head of the locking key, in its blocking position,
preventing said flexible tabs from deforming radially inwards.
9. The autoinjector according to claim 1, wherein said autoinjector
includes an actuator sleeve that includes a contact end for coming
into contact with the user's body, said actuator sleeve extending
inside said body at least in part, and being movable relative to
said body between projecting positions in which said actuator
sleeve projects out from said body at least in part, and an
actuated position in which said actuator sleeve is moved axially
into said body, said actuator sleeve being in a first projecting
position before actuation of the autoinjector, and in a second
projecting position after actuation of the autoinjector.
10. The autoinjector according to claim 1, wherein said reservoir
includes a needle through which said fluid is injected into said
injection site.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
This application is a National Stage of International Application
No. PCT/FR2016/051319 filed Jun. 2, 2016, claiming priority based
on French Patent Application No. 1555163 filed Jun. 5, 2016, the
contents of all of which are incorporated herein by reference in
their entirety.
The present invention relates to an autoinjector.
Autoinjectors are well known in the prior art. The purpose of such
devices is mainly to inject the contents of a syringe automatically
into a patient's body. Various systems exist for making the
penetration of the needle into the body of the patient and the
injection of the fluid contained in the syringe automatic.
Autoinjectors are relatively complex devices that must satisfy a
certain number of constraint requirements in order to be reliable.
The robustness of the device, its handling, and its ease of use for
the user are also important elements. In addition, since most
autoinjectors are for single use, the cost of manufacture and of
assembly is also a factor that needs to be taken into account.
Numerous autoinjectors exist on the market, but they present a
certain number of drawbacks.
Thus, in particular when the volume of fluid is relatively large
and/or when the injected fluid is relatively viscous, it is
desirable to enable the fluid to diffuse from the injection site
for a few seconds after said injection. When the user removes the
autoinjector immediately after the end of injection, a fraction of
the fluid may escape from the user's body, and this reduces the
effectiveness of the treatment. It is thus desirable to make
provision for the user to continue to hold the autoinjector against
the body for a few seconds after the end of injection. This aspect
is generally resolved in existing autoinjectors by the operating
instructions that ask the user to count silently a certain number
of seconds prior to removing the device. This is unreliable and
thus unsatisfactory, since the system depends on the user who, in
some circumstances, may be disturbed or weakened by the injection
action that has just been performed.
Documents WO 2013/178512, WO 2015/073740, WO 2011/101380, and US
2013/218093 describe prior-art autoinjectors.
An object of the present invention is to provide an autoinjector
that does not have the above-mentioned drawbacks, and that makes it
possible to satisfy the various major requirements and constraints
for safe and reliable use of the autoinjector.
Another object of the present invention is to provide an
autoinjector that is reliable in use, that enables the user to
determine when the autoinjector must be removed or may be removed
from the body after use, that is safe and that prevents any risk of
injury, and that is simple and inexpensive to manufacture and to
assemble.
The present invention thus provides an autoinjector comprising: a
body receiving a reservoir, said reservoir containing fluid and
including a piston, such as a pre-filled syringe; a piston rod that
is suitable for co-operating with the piston of said reservoir,
said piston rod being movable by an injection spring between a
primed position and an injection position in which said piston rod
has moved the piston of the reservoir so as to inject the fluid
into an injection site; and a visual, audible, and/or tactile
indicator device for indicating to the user that said autoinjector
may be removed from said injection site;
said autoinjector including a retarding system for delaying the
actuation of said visual, audible and/or tactile indicator device
relative to the end of injection, said retarding system including a
dashpot containing a fluid, a piston being arranged in said
dashpot, one of said dashpot and of said piston being movable in
translation in said body during actuation of said retarding system,
and the other of said dashpot and of said piston being stationary
relative to said body during actuation of said retarding system,
the movement in translation of one relative to the other moving
said fluid out from said dashpot through at least one flow passage,
such that said movement in translation is braked, said retarding
system comprising said dashpot containing said fluid, said piston,
a locking key, said injection spring, a pusher element, a support
member interposed between said pusher element and said injection
spring, and said piston rod.
Advantageously, during actuation of said retarding system, said
piston is movable in translation in said body, and said dashpot is
stationary.
Advantageously, during actuation of said retarding system, said
dashpot is prevented from moving in translation by a second
frustoconical or sloping wall portion of said body that co-operates
with at least one flexible tab of said dashpot, said piston, during
actuation of said retarding system, preventing said flexible tabs
from deforming radially inwards.
Advantageously, after actuating said retarding system, said piston
is moved axially relative to said at least one flexible tab of said
dashpot and no longer prevents it from deforming radially inwards,
such that said dashpot is no longer prevented from moving in
translation in said body.
Advantageously, said at least one flow passage is formed by an
axial groove in the dashpot.
Advantageously, said at least one flow passage is formed by a
central hole in the piston.
Advantageously, said pusher element is axially movable in said body
and co-operates with said piston, such that an axial movement of
said pusher element causes an axial movement of said piston in said
dashpot.
Advantageously, said locking key comprises a head, a longitudinal
rod, and an endpiece that is adapted to co-operate with the piston
rod, said head of the locking key being in its blocking position
before triggering the retarding system, in which position it
co-operates with a recess of said pusher element.
Advantageously, when the piston rod arrives towards its
end-of-injection position, it co-operates with the endpiece of the
locking key so as to pull said locking key axially downwards out
from its blocking position, such that said pusher element is thus
no longer prevented from moving in translation by said locking
key.
Advantageously, said pusher element includes flexible tabs that,
before actuation of the retarding system, co-operate with a first
frustoconical or sloping wall of the body, the head of the locking
key, in its blocking position, preventing said flexible tabs from
deforming radially inwards.
Advantageously, said autoinjector includes an actuator sleeve that
includes a contact end for coming into contact with the user's
body, said actuator sleeve extending inside said body at least in
part, and being movable relative to said body between projecting
positions in which said actuator sleeve projects out from said body
at least in part, and an actuated position in which said actuator
sleeve is moved axially into said body, said actuator sleeve being
in a first projecting position before actuation of the
autoinjector, and in a second projecting position after actuation
of the autoinjector.
Advantageously, said reservoir includes a needle through which said
fluid is injected into said injection site.
These characteristics and advantages and others of the present
invention appear more clearly from the following detailed
description, given by way of non-limiting examples, and with
reference to the accompanying drawings, and in which:
FIG. 1a is a diagrammatic side view of an autoinjector constituting
an advantageous embodiment of the present invention, in its rest
position, before-pricking;
FIGS. 1b and 1c are views similar to the view in FIG. 1a, in
section, on two different section planes;
FIGS. 2a to 2c are views similar to the views in FIGS. 1a to 1c, in
the after-pricking and before-injection position;
FIGS. 3a to 3c are views similar to the views in FIGS. 2a to 2c, in
the just prior to the end of injection position and at the moment
at which the retarding system is triggered;
FIGS. 4a and 4b are views similar to the views in FIGS. 3a and 3c,
at the beginning of actuating the retarding system;
FIGS. 5a to 5c are views similar to the views in FIGS. 3a to 3c, at
the end of actuating the retarding system;
FIGS. 6a to 6c are views similar to the views in FIGS. 3a to 3c, at
the end of actuating the indicator device, and before the
autoinjector has been removed from the injection site;
FIG. 7 is a view similar to the view in FIG. 6a, in the end-of-use
position, after the autoinjector has been removed from the
injection site;
FIG. 8 is an exploded perspective view of the retarding system of
said embodiment in FIGS. 1 to 7;
FIGS. 9 and 10 are fragmentary perspective views in section of the
FIG. 8 system, showing the unit formed by the fluid dashpot and the
piston, respectively before and during actuation of the retarding
system;
FIGS. 11 and 12 are perspective views of a detail of the unit
formed by the fluid dashpot and the piston, after actuating the
retarding system, respectively before and after the deformable tabs
of the dashpot have been deformed;
FIGS. 13 and 14 are views of a detail similar to the views in FIGS.
11 and 12, but in section, respectively before and after the
deformable tabs of the dashpot have been deformed;
FIG. 15 is a diagrammatic horizontal section view on section plane
A-A of FIG. 14;
FIGS. 16 to 18 are cut-away perspective views of a detail of the
FIG. 8 system, respectively before actuating, after actuating, and
at the end of actuating the retarding system;
FIG. 19 is a view similar to the views in FIGS. 16 to 18, at the
end of actuating the indicator device;
FIGS. 20a and 20b are diagrammatic views, respectively from the
side and in section, of an autoinjector constituting another
embodiment, in its rest position, before-pricking;
FIGS. 21a and 21b are views similar to the views in FIGS. 20a and
20b, in the after-pricking and before-injection position;
FIGS. 22a and 22b are views similar to the views in FIGS. 21a and
21b, in the just prior to the end of injection position and at the
moment at which the retarding system is triggered;
FIGS. 23a and 23b are views similar to the views in FIGS. 22a and
22b, at the beginning of actuating the retarding system;
FIGS. 24a to 24b are views similar to the views in FIGS. 23a to
23b, at the end of actuating the retarding system;
FIG. 24c is a view similar to the view in FIG. 24b on another
section plane;
FIGS. 25a to 25c are views similar to the views in FIGS. 24a to
24c, at the end of actuating the indicator device, and before the
autoinjector has been removed from the injection site;
FIG. 26 is a view similar to the view in FIG. 25a, in the
end-of-use position, after the autoinjector has been removed from
the injection site;
FIG. 27 is an exploded perspective view of the retarding system of
said embodiment in FIGS. 20 to 26;
FIGS. 28 to 30 are fragmentary perspective views in section of the
FIG. 27 system, showing the sub-assembly formed of the dashpot, the
piston, the locking key, and the spring, respectively at the start,
during, and at the end of actuation of the retarding system;
FIGS. 31 to 33 are cut-away perspective views of a detail of the
FIG. 27 system, respectively before actuating, after actuating, and
at the end of actuating the retarding system; and
FIG. 34 is a view similar to the views in FIGS. 31 to 33, at the
end of actuating the indicator device.
In the following description, the terms "top", "bottom", "high",
and "low" refer to the positions shown in FIGS. 1a to 7, 17, 18,
and 20a to 26. The terms "axial" and "radial" refer to the
longitudinal central axis X, shown in particular in FIGS. 1a and
20a, that corresponds to the longitudinal axis of the needle.
The autoinjector is described below with reference to two
advantageous embodiments. It should nevertheless be observed that
autoinjectors, which are complex appliances, comprise a plurality
of modules for performing a plurality of functions. The various
modules may be used separately and independently of one another,
without necessarily being combined with the other modules, and in
particular they could be used in autoinjectors of shape that is
different from the shape shown in the drawings. Furthermore, it
should be observed that the drawings are diagrammatic views, which
do not necessarily represent the exact shape of the components of
an autoinjector, and they are not necessarily to scale, in
particular for purposes of clarity. In addition, the drawings do
not necessarily represent all of the component elements of an
autoinjector, but only the elements necessary for operation of the
present invention. Thus, various additional and/or complementary
elements and modules could be associated with the autoinjector
shown in the figures.
The autoinjector shown in the figures comprises a body 1 in which
an actuator sleeve 10 slides axially, the actuator sleeve 10 having
a bottom end 101 that is for coming into contact with the body of
the patient around the injection zone. In the embodiment in FIGS. 1
to 19, the autoinjector includes a lower body 1a and an upper body
1c that are assembled together so as to form the body 1 of the
autoinjector. In the embodiment in FIGS. 20 to 34, the autoinjector
includes a lower body 1a, an intermediate body 1b, and an upper
body 1c that are assembled together so as to form the body 1 of the
autoinjector. Below, the term "body" and the numerical reference
"1" are used to designate said unitary body formed by assembling
said lower body 1a with said intermediate body 1b and/or said upper
body 1c. It should be observed that the body 1 could be formed of
any number of body portions, and that the embodiments in the
figures, with two or three body portions, are not limiting.
A reservoir S may be inserted into said body 1 of the autoinjector,
said reservoir S preferably being stationary in said body 1. The
reservoir S contains fluid and includes a piston P and a needle A.
The piston P is adapted to move in said reservoir S so as to inject
the fluid through said needle A. Optionally, the present invention
could also apply to a reservoir that does not have a needle, in
particular in an injection device that does not have a needle.
The present description is made with reference to a syringe S that
may be of any type. More generally, it is understood that the term
"syringe" in the present description encompasses any type of
reservoir associated with a needle. Preferably, the reservoir S is
a pre-filled syringe.
Before the autoinjector is actuated, the needle A of the syringe S
can be protected by a guard (not shown), the autoinjector possibly
including a cap (not shown) that the user can remove before
actuation. Removal of the cap advantageously causes the guard to be
removed.
Before actuation, the actuator sleeve 10 is in a first projecting
position in which it surrounds the needle A, as shown in FIGS. 1a
and 1b firstly, and 20a and 20b secondly. During actuation, the
actuator sleeve 10 slides inside the body 1 towards an actuated
position, so as to expose the needle A and enable pricking, and
then injection of the fluid.
After injection, when the user removes the autoinjector from the
injection site, the actuator sleeve 10 returns into an end-of-use
second projecting position in which it is once again arranged
around the needle A, so as to avoid any risk of injury with said
needle, as shown in FIGS. 6 and 26.
The actuator sleeve 10 is advantageously urged towards its
projecting positions by a resilient member or spring 190 that may
be of any type. Advantageously, in said end-of-use position, said
actuator sleeve 10 is locked, and can no longer be moved axially
into said body 1. By way of example, locking may be achieved by
tabs (not shown) that are secured to the body 1 or to the reservoir
S, and that co-operate with openings (not shown) in said actuator
sleeve 10 when said actuator sleeve reaches its second projecting
position. Locking, that is not essential to the operation of the
present invention, is not described in greater detail below. It
could be achieved in ways that are different from the particular
embodiment mentioned above. In particular, it could be achieved in
accordance with the teaching of documents WO 2013/175140 or WO
2013/175142.
The autoinjector also includes an automatic injection system, in
particular comprising a piston rod 5 that is adapted to co-operate
with the piston P so as to move it in the reservoir S so as to
dispense the fluid through the needle A. Conventionally, the piston
rod 5 is urged by an injection spring 8 towards its dispensing
position and, before actuation, it is held in its rest position by
an appropriate injection lock.
An advantageous injection lock is described in particular in
document WO 2015/155484.
The lock may comprises at least one blocking element 7 that is held
in its blocking position by a blocking ring 230 that is fastened,
in particular snap-fastened, on a support member 6 against which
the injection spring 8 bears. Triggering said injection lock causes
said injection means to be actuated, and thus fluid to be injected
through the needle. Said injection lock may further include a
control sleeve 4 that is arranged in said body 1, said control
sleeve 4 containing said piston rod 5 and said injection spring 8,
said piston rod 5 including a radial recess that receives at least
one blocking element 7 that is movable between a blocking position
and an unblocking position. Said at least one blocking element 7 is
preferably of shape that is substantially spherical, such as a
ball. Advantageously, said balls are urged radially outwards by
said piston rod 5 and they are held in their blocking position by
the blocking ring 230. The blocking ring 230 is axially movable
relative to said piston rod 5 and relative to said support member 6
between a locking position in which it holds said balls in their
blocking position, and an unlocking position in which said balls
are released thereby unblocking said injection lock, enabling said
injection spring 8 to move said piston rod 5 towards its injection
position. In particular, the blocking ring 230 may be moved towards
its unlocking position by said control sleeve 4.
When the needle A of the syringe S has penetrated the user's body,
the blocking ring 230 is moved axially upwards, thereby causing the
balls 7 to be released from their blocking position, said balls
then moving radially outwards. The piston rod 5 is then no longer
held by the balls, and it is thus moved axially downwards so as to
inject the fluid.
The autoinjector includes a visual, audible, and/or tactile
indicator device for indicating to the user, in particular by an
audible sound, by vibration, and/or by visual and/or tactile
indication, that the autoinjector may be removed from the injection
site. Said visual, audible, and/or tactile indicator device is
preferably arranged at the rear end of said body 1, remote from
said injection site. In particular, in the embodiments shown, the
indicator device includes an indicator element that gives visual
indication, by a suitable display 160 in one or more windows 11 of
the body 1. Advantageously, audible and/or tactile indication can
also be provided, as described in greater detail below.
In order to avoid the user removing the autoinjector from the
injection site as soon as injection ends, the autoinjector includes
a retarding system that delays actuating said indicator device
relative to the end of injection.
FIGS. 8 to 19 show a retarding system of an advantageous embodiment
of the invention, and FIGS. 27 to 34 show a retarding system of
another advantageous embodiment.
The main purpose of the retarding system is to put off starting the
visual, audible, and/or tactile indication after the end of
injecting the fluid into said body. In particular, this enables the
fluid to diffuse for a few seconds after it has been injected. Such
a retarding system also provides a benefit for the user, who no
longer has to count, e.g. up to 10, after being injected, where it
is possible that the time taken to perform such counting might vary
greatly from one user to another. With a retarding system, the
sequence of using an autoinjector is facilitated.
The mechanical retarding system thus makes it possible to put off
starting the end-of-use indicator by a few seconds relative to the
end of injection, this delay being predeterminable.
The invention makes use of the phenomenon of fluid transfer for
generating said delay, and uses a dashpot 16, a piston 19 that
slides axially in said dashpot 16, and a fluid arranged in said
dashpot 16 and adapted to be moved by said piston 19, when said
piston moves in said dashpot 16.
In the embodiments shown, during actuation of the retarding system,
the dashpot 16 is stationary relative to the body 1, and the piston
19 is axially movable relative to said dashpot 16. However, the
inverse configuration can also be envisaged.
A fluid is arranged in said dashpot 16, axially above said piston
19, said fluid being adapted to flow out from said dashpot while
said piston 19 is being moved in said dashpot 16. The fluid may
flow into another chamber of the dashpot or merely out from said
dashpot. It may flow through one or more flow passages that are
dimensioned so as to brake the movement of said piston 19 in said
dashpot 16.
Depending on the viscosity of the fluid contained in the dashpot 16
and/or depending on the shapes and dimensions of the dashpot 16, of
the piston 19, and/or of the flow passages, it is possible to
adjust said braking quite accurately, and thus to adjust the time
between the beginning and the end of actuating the retarding
system. At the end of actuating the retarding system, the dashpot
16 may move axially in the body 1 so as to provide the indication,
and in particular to indicate in the window 11 of the indicator
that the autoinjector may be removed from the injection site.
Actuating the visual, audible, and/or tactile indicator device is
thus delayed relative to the end of injection, thereby enabling the
injected fluid to diffuse in the injection site during this period
of delay.
FIG. 8 is an exploded diagrammatic perspective view of the
retarding system of an advantageous embodiment of the invention.
The retarding system comprises the upper body 1c, the dashpot 16
containing an appropriate fluid, the piston 19 that slides in said
dashpot 16, a pusher element 17, a locking key 20, the piston rod
5, the support member 6, and the injection spring 8. The pusher
element 17 is advantageously fastened, in particular snap-fastened,
on said support member 6 of the injection lock.
In this embodiment, the body 1 is made up of only two portions, a
lower body portion 1a and an upper body portion 1c. In this
embodiment, there is thus no intermediate body portion.
In the embodiment shown, the dashpot 16 also forms an indicator
element of the visual, audible, and/or tactile indicator device.
Advantageously, said dashpot 16 may include an appropriate
projection 160 for indicating the end of use of the autoinjector in
one or more windows 11 of the body 1, in particular of the upper
body 1c. In the embodiment shown in FIGS. 1 to 19, the body 1
includes a single window 11.
The pusher element 17 is axially movable in said body 1, and
co-operates with said piston 19. While said piston 19 is being
moved axially, the dashpot 16 is prevented from performing any
axial movement. Thus, axial movement of said pusher element 17
causes axial movement of the piston 19 in the dashpot 16. In a
variant, the inverse configuration could be envisaged, namely that
the pusher element 17 moves a movable dashpot relative to a
stationary piston.
The locking key 20 comprises a head 21 that is adapted to
co-operate with the retarding system, a longitudinal rod 22, and an
endpiece 23 that is adapted to co-operate with the piston rod
5.
In the position prior to triggering the retarding system, the head
21 of the locking key 20 is in its blocking position in which it
co-operates with an axial recess 170 of the pusher element 17, such
that said pusher element is prevented from moving in translation by
said key. When the piston rod 5 comes towards its end-of-injection
position, it co-operates with the endpiece 23 of the locking key
20, and thus pulls said locking key axially downwards. As a result,
the head 21 of said locking key 20 moves axially out from said
recess 170, such that said pusher element 17 is no longer prevented
from moving in translation by said key 20.
The injection spring 8 urges the pusher element 17 to move axially
in translation towards the rear of said upper body 1c. While the
pusher element 17 is blocked by said locking key 20, the retarding
system is thus also blocked.
In the embodiment shown, before actuation of the retarding system,
the pusher element 17 is prevented from performing any axially
upward movement by a first frustoconical or sloping wall 109 of the
upper body 1c, which wall co-operates with flexible tabs 179 of
said pusher element 17. In the embodiment shown, there are two
diametrically-opposite flexible tabs 179, but a different number of
first flexible tabs could be envisaged, e.g. a single tab, or more
than two tabs. As can be seen in FIG. 16 in particular, in its
blocking position, said head 21 of the locking key 20 prevents said
flexible tabs 179 of the pusher element 17 from deforming radially
inwards. When said head 21 is no longer in its blocking position,
said flexible tabs 179 can deform radially inwards under the effect
of the injection spring 8 that pushes said pusher element 17
axially upwards, and as a result of the co-operation between said
flexible tabs 179 and the first sloping wall 109 of the body 1.
When said locking key 20 releases said pusher element 17 at the end
of injection, said pusher element is thus moved axially by said
injection spring 8. The retarding system is thus triggered, with
said pusher element 17 co-operating with said piston 19 so as to
move it axially in said dashpot 16. This causes the fluid to be
transferred out from said dashpot 16 through appropriate flow
passages 161. In the embodiment shown, the flow passages are formed
by axial grooves formed in said dashpot 16, as can be seen in FIG.
15 in particular. Arrows F in FIG. 10 show the transfer of fluid.
The speed of axial movement of the pusher element 17 thus
corresponds to the speed of axial movement of said piston 19 that
is subjected to braking as a result of transferring the fluid out
from the dashpot 16 through said flow passages 161.
While said piston 19 is moving in said dashpot 16, said dashpot is
prevented from performing any axial movement by flexible tabs 168
of said dashpot 16 that co-operate with a second sloping wall 108
of the body 1, as can be seen in FIG. 13. In the embodiment shown,
there are two diametrically-opposite flexible tabs 168, but a
different number of flexible tabs could be envisaged, e.g. a single
tab, or more than two tabs. As can be seen in FIGS. 16 and 17 in
particular, while the piston 19 has not ended its axial movement in
said dashpot 16, it prevents said flexible tabs 168 of the dashpot
16 from deforming radially inwards. When said piston 19 has ended
its axial movement in said dashpot 16, it no longer blocks said
flexible tabs 168, which can then deform radially inwards under the
effect of the injection spring 8 that pushes the unit formed by
said pusher element 17, said piston 19, and said dashpot 16 axially
upwards, and as a result of the co-operation between said flexible
tabs 168 and the second sloping wall 108 of the body 1. This can be
seen in FIG. 14 in particular.
When said piston 19 has ended its axial movement in said dashpot
16, said dashpot is thus released from being blocked, and the unit
formed of the pusher element 17, of the piston 19, and of the
dashpot 16 is thus projected by the injection spring 8 axially
against the end wall of the upper body 1c, as shown in FIG. 19. The
indicator portion 160 of the dashpot 16 is thus arranged facing the
indication window 11 of the body 1. This non-braked movement or
projection of said unit also makes it possible to generate an
audible indication by contact between the dashpot 16, the piston
19, and/or the pusher element 17, with the body 1. This audible
indication may be made at said indicator portion 160 or on another
portion of the unit formed by the pusher element 17, the piston 19,
and the dashpot 16, that is adapted to co-operate with an
appropriate portion of the body 1. It should be observed that the
impact that generates the audible indication may also provide
tactile indication by causing the autoinjector to vibrate in the
user's hand, which is useful in particular for the hard of
hearing.
FIG. 27 is an exploded diagrammatic perspective view of the
retarding system of another advantageous embodiment. The retarding
system comprises the upper body 1c, the dashpot 16 containing an
appropriate fluid, the piston 19 arranged in said dashpot 16, a
retarding spring 18, a locking key 20, the piston rod 5, and the
intermediate body 1b.
In the embodiment shown, the dashpot 16 also forms an indicator
element of the visual, audible, and/or tactile indicator device.
Advantageously, said dashpot 16 may include an appropriate
projection 160 for indicating the end of use of the autoinjector in
one or more windows 11 of the body 1, in particular of the upper
body 1c. In the embodiment shown in FIGS. 20 to 34, the body 1
includes a single window 11.
The spring 18 bears firstly against the intermediate body 1b, and
secondly against the piston 19, as can be seen in FIGS. 31 to 34 in
particular. In a variant, said spring could co-operate with the
dashpot.
The locking key 20 comprises a head 21 that is adapted to
co-operate with the retarding system, a longitudinal rod 22, and an
endpiece 23 that is adapted to co-operate with the piston rod
5.
In the position prior to triggering the retarding system, the head
21 of the locking key 20 is in its blocking position in which it
co-operates with an axial recess 190 of the piston 19, such that
said piston is prevented from moving in translation by said key.
When the piston rod 5 comes towards its end-of-injection position,
it co-operates with the endpiece 23 of the locking key 20, and thus
pulls said locking key axially downwards. As a result, the head 21
of said locking key 20 moves axially out from said recess 190, such
that said piston 19 is no longer prevented from moving in
translation by said key 20.
The spring 18 urges the piston 19 to move axially in translation
towards the rear of said upper body 1c. While the piston 19 is
blocked by said locking key 20, the retarding system is thus also
blocked.
In the embodiment shown, before actuation of the retarding system,
the piston 19 is prevented from performing any axially upward
movement by a first frustoconical or sloping wall 109 of the upper
body 1c, which wall co-operates with flexible tabs 199 of said
piston 19. In the embodiment shown, there are two
diametrically-opposite flexible tabs 199, but a different number of
first flexible tabs could be envisaged, e.g. a single tab, or more
than two tabs. As can be seen in FIG. 31 in particular, in its
blocking position, said head 21 of the locking key 20 prevents said
flexible tabs 199 of the piston 19 from deforming radially inwards.
When said head 21 is no longer in its blocking position, said
flexible tabs 199 can deform radially inwards under the effect of
the spring 18 that pushes said piston 19 axially upwards, and as a
result of the co-operation between said flexible tabs 199 and the
first sloping wall 109 of the body 1.
When said locking key 20 releases said piston 19 at the end of
injection, said piston is thus moved axially by said spring 18. The
retarding system is thus triggered, with said piston 19 moving
axially in said dashpot 16. This causes the fluid to be transferred
out from said dashpot 16 through one or more appropriate flow
passages 195. In the embodiment shown, the flow passage is formed
by a central hole in the piston 19, as can be seen in FIGS. 31 to
33 in particular. The central hole axially extends said recess 190
of the piston 19. Advantageously, before actuating the retarding
system, the central hole is closed by said head 21 of said locking
key 20, thereby makes it possible to seal the dashpot 16. The speed
of axial movement of the piston 19 is thus subjected to braking as
a result of transferring the fluid out from the dashpot 16 through
said flow passage 195.
While said piston 19 is moving in said dashpot 16, said dashpot is
prevented from performing any axial movement by flexible tabs 168
of said dashpot 16 that co-operate with a second sloping wall 108
of the body 1, as can be seen in FIGS. 31 and 32. In the embodiment
shown, there are two diametrically-opposite flexible tabs 168, but
a different number of flexible tabs could be envisaged, e.g. a
single tab, or more than two tabs. While the piston 19 has not
ended its axial movement in said dashpot 16, it prevents said
flexible tabs 168 of the dashpot 16 from deforming radially
inwards. When said piston 19 has ended its axial movement in said
dashpot 16, it no longer blocks said flexible tabs 168, which can
then deform radially inwards under the effect of the spring 18 that
pushes the unit formed by said piston 19 and said dashpot 16
axially upwards, and as a result of the co-operation between said
flexible tabs 168 and the second sloping wall 108 of the body 1.
This can be seen in FIG. 34 in particular.
When said piston 19 has ended its axial movement in said dashpot
16, said dashpot is thus released from being blocked, and the unit
formed of the piston 19 and of the dashpot 16 is thus projected by
the spring 18 axially against the end wall of the upper body 1c, as
shown in FIG. 34. The indicator portion 160 of the dashpot 16 is
thus arranged facing the indication window 11 of the body 1. This
non-braked movement or projection of said unit also makes it
possible to generate an audible indication by contact between the
dashpot 16 and/or the piston 19, with the body 1. This audible
indication may be made at said indicator portion 160 or on another
portion of the unit formed by the piston 19 and the dashpot 16,
that is adapted to co-operate with an appropriate portion of the
body 1. It should be observed that the impact that generates the
audible indication may also provide tactile indication by causing
the autoinjector to vibrate in the user's hand, which is useful in
particular for the hard of hearing.
In both of the embodiments described above, the fluid used in the
retarding system may be of any appropriate type, e.g. grease. The
use of a fluid having viscoelastic properties is advantageous.
The retarding device thus makes it possible to offset, by a
predetermined time, the moment at which the indicator indicates the
end of use, from the moment at which the injection stage has
ended.
A complete actuation stage of the autoinjector is described
below.
When the user wishes to use the autoinjector, the user takes hold
of the device, e.g. at the body 1, and presses the actuator sleeve
10, which at rest, in its first projecting position, projects out
from the lower body 1, against the part of the body where the
injection is to be performed. In FIG. 1a, 1b and 2a, 2b firstly,
and 20a, 20b and 21a, 21b secondly, it can be seen that the
pressure exerted by the user on the actuator sleeve 10 causes said
actuator sleeve to slide inside the body 1, thereby uncovering the
needle and thus pricking the user as a result of the pressure
exerted by the user on the autoinjector.
When the actuator sleeve 10 reaches its actuated position, which is
its end position inside the body 1, it causes the injection stage
to be triggered, which is shown in FIGS. 3a, 3b and 4a, 4b firstly,
and 22a, 22b and 23a, 23b secondly. It should be observed that the
piston rod 5 slides inside the syringe A, pushing the piston P of
said syringe under the effect of the injection spring 8. The fluid
is thus dispensed.
At the end of injection, the retarding system is triggered, such
that the indicator device is actuated only after a predetermined
time delay.
After indicating the end of use, when the user removes the
autoinjector from the injection site, the actuator sleeve 10 once
again moves out from the body 1 towards the end-of-use position,
which is its second projecting position, under the effect of the
spring of the actuator sleeve, with said actuator sleeve 10 being
locked, and this guarantees absolute safety for the user and avoids
any risk of injury with the needle after the device has been
used.
In the embodiment shown, the first and second projecting positions
of the actuator sleeve are different positions, however it should
be observed that they could optionally be identical.
The present invention applies to devices used in particular for
treatment of auto-immune diseases, e.g. of the rheumatoid
arthritis, multiple scleroses, Crohn's disease type, for treatment
of cancer, for antiviral treatments, e.g. of the hepatitis type,
for treatment of diabetes, for treatment of anemia, or for
treatment of allergy attacks, e.g. in the event of anaphylactic
shock.
Although the present invention is described above with reference to
an advantageous embodiment, naturally said embodiment is not
limiting. In particular, the actuator sleeve and/or the injection
lock and/or the retarding device and/or the audible and/or tactile
indicator device could be made in some other way. Pricking by the
needle and/or retracting the needle after injection could be
controlled by one or more buttons. Other modifications can also be
envisaged by the person skilled in the art, without going beyond
the ambit of the present invention, as defined by the accompanying
claims.
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